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510(k) Data Aggregation

    K Number
    K011808
    Device Name
    ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
    Manufacturer
    ASIA-MED GMBH AND CO KG
    Date Cleared
    2001-07-10

    (29 days)

    Product Code
    MQX,MOX
    Regulation Number
    880.5580
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

    Device Description

    asia-med acupuncture needles (Special, Standard, Compact and Apex) for single use.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for acupuncture needles. It does not contain information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt.

    Therefore, I cannot provide the requested information based on the input text.

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